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Trial registered on ANZCTR


Registration number
ACTRN12623000598684p
Ethics application status
Not yet submitted
Date submitted
1/05/2023
Date registered
1/06/2023
Date last updated
1/06/2023
Date data sharing statement initially provided
1/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Co-Designing, Evaluating, and Implementing Supportive Care for Endometriosis (CoDeEndo)
Scientific title
Co-Designing and implementing 'CoDeEndo': a modular telehealth-based supportive care program and evaluating its impact on pain and quality of life for people with endometriosis.
Secondary ID [1] 309550 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CoDeEndo
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 329839 0
Pain 329840 0
Condition category
Condition code
Reproductive Health and Childbirth 326750 326750 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CoDeEndo is a modular telehealth-based supportive care program for people with endometriosis.

Phase 1 of the study will occur over 10 months and involve refining the structure of CoDeEndo (as a whole model) utilising workshops and interviews with consumers, their representatives, and interdisciplinary healthcare professionals.

Phase 2 will follow phase 1 and will occur over 34 months. Phase 2 will evaluate the efficacy of CoDeEndo (versus education) as follows: CoDeEndo is an adaptive and flexible self-guided intervention where the dose and the content of the intervention is individualised to each person, based on their needs and attributes. A screening algorithm built into the online platform suggests the order of the modules to be taken based on needs. However, participants will have access to all the modules and the algorithm only dictates their order. CoDeEndo includes eight modules that are evidence-based, self-directed and comprised of a mix of video, podcasts and written resources, which have been developed by our team for people with endometriosis or other chronic pelvic conditions to assist participants to master new skills through practical activities. They involve psychological, movement and dietary approaches to target poor QoL, pain, fatigue, gut symptoms, anxiety, depression and infertility, and are provided during and in addition to usual medical care. Participants will receive email notifications every week directing them to information and resources within CoDeEndo and will be able to access each module as needed. Each weekly recording will go for between 1-2 hours, with the total weekly time commitment being no more than three hours. Participants’ adherence to the intervention will be monitored using Google analytics. Each week, participants who have not interacted with the program will be followed up by email about willingness to continue participation and discuss potential problems.

Phase 2 a will also examine if CoDeEndo is cost-effective as compared to education from both health system (i.e., healthcare utilisation) and societal perspectives based on quality-of-life data.
Intervention code [1] 325976 0
Behaviour
Intervention code [2] 325977 0
Lifestyle
Intervention code [3] 326054 0
Treatment: Other
Comparator / control treatment
Waitlist control: Participants randomised to waitlist will continue their usual medical care and will be offered CoDeEndo at the end of their time in the study (6 months post-randomisation).
Control group
Active

Outcomes
Primary outcome [1] 334604 0
Endometriosis-related quality of life measured by the 30-item endometriosis Health Profile (EHP-30)
Timepoint [1] 334604 0
Baseline, post-treatment at 8 weeks and 6 months (primary endpoint) since baseline
Primary outcome [2] 334605 0
Quality of life will be measured by the Euroqol (EQ)-5D-5L
Timepoint [2] 334605 0
Baseline, post-treatment at 8 weeks and 6 months (primary endpoint) since baseline
Secondary outcome [1] 421377 0
Pain and functioning with the Brief Pain Inventory (BPI)
Timepoint [1] 421377 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [2] 421378 0
Self-efficacy with the Pain Self-Efficacy Questionnaire (PSEQ)
Timepoint [2] 421378 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [3] 421379 0
Psychological symptoms with the Depression Anxiety Stress Scale - 21 items (DASS-21)
Timepoint [3] 421379 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [4] 421380 0
Fatigue with the Fatigue Symptom Inventory (FSI)
Timepoint [4] 421380 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [5] 421381 0
Menstrual symptoms with the Menstrual Symptoms Questionnaire (MSQ)
Timepoint [5] 421381 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [6] 421382 0
Health utilisation and cost data will be collected via a consumer Resource Use Questionnaire and employment questionnaire, including hospitalisation use, length of stay, diagnostic tests, hospital attendance with no admission community allied health visits related to endometriosis and any other related out-of-pocket expenses, e.g., transportation, child care. Medicare Australia records will be retrieved for consented participants to determine medical services and pharmaceutical use.
Timepoint [6] 421382 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [7] 421383 0
Gastrointestinal symptom data will be collected using the Gastrointestinal Symptom Rating Scale (GSRS), a 7-level Likert scale (1–7), based on the intensity and frequency of GI symptoms experienced during the previous seven days.
Timepoint [7] 421383 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [8] 421384 0
Diet data on a 3-day food diary (composite: energy, nutrient and FODMAP intake on Foodworks and the Monash FODMAP calculator)
Timepoint [8] 421384 0
Baseline, post-treatment at 8 weeks and 6 months since baseline

Eligibility
Key inclusion criteria
Participants will be adults with a diagnosis of endometriosis by a qualified physician (confirmed by histology, operation reports, and/or ultrasound scan), capacity for consent, sufficient level of English to understand the intervention and be able answer relevant questionnaires via internet (individually or with support).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with severe mental illness or cognitive impairment, as confirmed on psychological screening, and those who are pregnant will be excluded and provided with external support resources.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A block randomisation sequence with variable block size will be embedded in Qualtrics by the study biostatistician for allocation concealment. The biostatistician will not be involved in participant recruitment and will be blinded to allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting participants will be randomly assigned (1:1 ratio) to CoDeEndo or education following completion of baseline questionnaires. A block randomisation sequence with variable block size will be embedded in Qualtrics for allocation concealment. The biostatistician will be blinded to allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All statistical analyses will be conducted on an intention-to-treat basis. The intervention effect over 6 months on the primary outcomes (EHP-30 and EQ-5D-5L) and the secondary outcomes will be estimated using linear mixed models. The models will include study arm, time (T1, T2, T3) and time by study arm interaction as fixed effects, and participant as random effect. Reasons for non-completion will be collected. Multiple imputation will be used for missing data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
246
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313742 0
Government body
Name [1] 313742 0
National Health and Medical Research Council
Country [1] 313742 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
Geelong Waurn Ponds Campus
Locked Bag 20000
Geelong VIC 3220
Country
Australia
Secondary sponsor category [1] 315558 0
None
Name [1] 315558 0
Address [1] 315558 0
Country [1] 315558 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 312914 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 312914 0
Human Research Ethics Office Deakin University 221 Burwood Hwy Burwood, VIC 3125
Ethics committee country [1] 312914 0
Australia
Date submitted for ethics approval [1] 312914 0
19/06/2023
Approval date [1] 312914 0
Ethics approval number [1] 312914 0

Summary
Brief summary
Endometriosis is a chronic condition in which tissue similar to that lining the uterus grows on other organs, leading to scarring and adhesions and causing pain, menstrual irregularities, and infertility. Impacting 11% of Australian women and those assigned female at birth, endometriosis is under-recognised due to the variability in symptoms, reliance on surgery for diagnosis, and stigma of menstruation. Usual care, comprising of hormone and pain medications, has limited efficacy, is associated with adverse effects, and is discontinued by up to 40% of people.
Recognising the inadequacy of the current biomedical healthcare approach to treating endometriosis, there is a need to address the complex psychosocial burden of endometriosis, and there are calls for urgent improvements in access to consumer-centred pain management.
The current project will firstly refine the structure of and evaluate the efficacy of ‘CoDeEndo’ – a modular telehealth-based supportive care program for endometriosis. The project will then implement ‘CoDeEndo’ within a randomised controlled trial comparing ‘CoDeEndo’ with waitlist control, to evaluate the impact of ‘CoDeEndo’ on pain, mental health and quality of life in people with endometriosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126314 0
Prof Antonina Mikocka-Walus
Address 126314 0
Deakin University School of Psychology 221 Burwood Hwy Burwood 3125 VIC
Country 126314 0
Australia
Phone 126314 0
+61392468575
Fax 126314 0
Email 126314 0
mikocka@deakin.edu.au
Contact person for public queries
Name 126315 0
Mrs Elesha Parigi
Address 126315 0
Deakin University 1 Gheringhap Street, Geelong, VIC. 3220
Country 126315 0
Australia
Phone 126315 0
+61 3 522 73612
Fax 126315 0
Email 126315 0
codeendo@deakin.edu.au
Contact person for scientific queries
Name 126316 0
Prof Antonina Mikocka-Walus
Address 126316 0
Deakin University School of Psychology 221 Burwood Hwy Burwood 3125 VIC
Country 126316 0
Australia
Phone 126316 0
+61392468575
Fax 126316 0
Email 126316 0
mikocka@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We believe participants (a chronically ill cohort) may be reluctant to participate if we decided to share their health-related data. Further, we are initiating a program of research in this area and want our team to be able to use the data in future publications. This is not a large dataset and thus by opening it to others we might lose the opportunity to publish the data ourselves.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.